在临床试验数据分析中，生成SDTM、ADaM的Define之后，我们会用Pinnacle 21软件进行检测其是否符合CDSIC的标准。对于软件生成的issue (ERROR, WARNING)，我们要进行解释, 对于ADaM，通常解释附在提交Analysis Data Reviewer’s Guide文件中(adrg.pdf)。文件中的Issue Summary会对Pinnacle 21检测出的问题一一解释。下面我来分享下一些，常见Issue的解释说明：
| Source | Finding | Explanation |
|---|---|---|
| Define | Unknown NCI Code value for Codelist 'DATEFL' | False positive due to a known issue in Pinnacle 21 Community v2.1.1 |
| ADAB, ADAU, ADBMDXA, ADBMHMR, ADBMMCT, ADBMXCT, ADBPI, ADEQ5D, ADLAD, ADLB, ADLBHY, ADMI, ADOPAQ, ADOR, ADSL, ADVS, ADWOMAC | Variable label mismatch between dataset and ADaM standard | Company doen't change Variable label, and only add descriptive wording as the general label from the ADaM IG are too high-level to be meaningful in our study. For e.g. we defined ADAB.ANL01FL as "Analysis Record Flag in Visit Window"; ADAB.ANL06FL as "Last Post Baseline in 1st. Anal Interval" to provide clear and informative analysis results metadata about the records used for an analysis. Here are the variables Company add descriptive information into variable label: ANLxxFL, CHGCAT1, CRIT1FL, and PARCAT1 |
| ADAB, ADADJCV, ADAECX, ADAEFX, ADAU, ADBLHR, ADBMDXA, ADBMHMR, ADBMMCT, ADBMXCT, ADBPI, ADCM, ADDV, ADEQ5D, ADEX, ADEXSUM, ADFXSUM, ADLAD, ADLB, ADLBHY, ADMH, ADMI, ADOPAQ, ADOR, ADPC, ADSRMPP, ADTTEE, ADTTES, ADVFXR, ADVS, ADWOMAC | Required variable is not present | Based on the draft ADaM IG version 1.1 and official CDISC training, we did not create TRTP as it was not an appropriate treatment variable for analysis. Another ADSL treatment variable is used instead. |
| ADBLHR, ADCM, ADDV, ADEX, ADMH, ADPC | Required variable is not present | The variables PARAM and PARAMCD are not expected since these datasets are not constructed to use the BDS structure. |
| ADPC | *TM is not a numeric variable | The variable is PCELTM and comes from SDTM PC domain. It follows the ISO8601 format and in character format. |
| ADADJCV, ADAECX, ADAEFX, ADBLHR, ADCM, ADDV, ADEX, ADMH | Neither AVAL nor AVALC are present in dataset | The data didn’t use BDS structure, so AVAL or AVALC is not available. |
| ADLBHY | Inconsistent value for AVALCAT1 | This is Company standard and acceptable. |
| ADBPI | Calculation issue: BASE = 0 but PCHG is populated | If BASE=0 and AVAL is not missing, then PCHG is equal to ((AVAL-0.5)/0.5)*100 and so populated. |
| ADAE | AEACN value not found in 'Action Taken with Study Treatment' non-extensible codelist | ‘DOSE ALTERED OR WITHHELD’ is the Company defined value and acceptable. |
| ADAB, ADADJCV, ADAE, ADAECX, ADAEFX, ADBLHR, ADBMDXA, ADBPI, ADCM, ADDV, ADEQ5D, ADEX, ADEXSUM, ADFXSUM, ADLAD, ADLB, ADLBHY, ADMH, ADOPAQ, ADOR, ADSL, ADSRMPP, ADTTEE, ADTTES, ADVFXR, ADVS | Value for RACE not found in (RACE) user-defined codelist | ‘MULTIPLE’ is Company define value and acceptable. |
| ADSL | TRTEDT != Maximum TRxxEDT on this record | Alendronate treatment start and end dates have partial dates. Character date TRTEDTC=Maximum TRxxEDTC on this record. |
| ADLB | DTYPE value not found in 'Derivation Type' extensible codelist | ‘BQL’ and ‘SDTM-AVERAGE’ are Company define value and acceptable. |
网友评论